General Summary

The Regulatory Affairs Manager will be responsible for leading ASO’s Regulatory and Compliance directives carrying out a wide range of initiatives while ensuring compliance to FDA and other regulatory bodies/entities in addition ensuring adherence to the Quality Management System.

Key Responsibilities

• Works with internal stakeholders, regulatory agencies/bodies, and consultants as required to ensure product-specific regulatory compliance.

• Manages Regulatory Risk Assessments per ISO 14971.

• Acts as the main primary Person Responsible for Regulatory Compliance for Europe (PRRC) and Health Canada (HC).

• Supports Quality System as needed meeting ISO 13485 standards.

• Confirms FDA product codes under 21 CFR for new products and assisting with assessment of regulatory requirements for launching new products.

• Develops and maintains appropriate reports from regulatory and compliance perspective.

• Proposes regulatory submission strategies in support of business strategies.

• Reviews claims and product labeling for all ASO product.

• Responds to customer issues, questions and concerns related to ASO product.

• Responsible for classification review of new commercial products, existing commercial products upon regulatory change, raw materials, all imported materials, etc.

• Creates and maintains product regulatory files/ records relating to ASO products.

• Stays abreast and interpret regulatory codes, rules or code changes and ensure that they are communicated through corporate policies and procedures. Maintain current knowledge base of existing and emerging

regulations, standards, or guidance documents.

• Recommends changes to company procedures in response to changes in regulations or standards.

• Performs and maintains a regulatory risk assessment and provide timely recommendations and projects related to the company

• Develops and maintains regulatory network (formal and informal) by establishing relationships with various regulatory bodies, local consultants and legal entities within the respective countries / regions where ASO has

business interests.

• Supports internal and external audits

• Other duties as assigned

Qualifications

To perform this job successfully, an individual should be able to perform each essential duty / key responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability preferred. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education

Bachelor’s degree in Quality, Regulatory Affairs or an applicable science (Engineering) required. Masters preferred.

Experience

Minimum of 7+ years of Regulatory experience within an FDA regulated industry. Understanding of Regulatory requirements for Medical Devices under ISO 13485 MDSAP. Understanding of 510K, NDA, ANDA, and OTC guidelines is required. Medical Device Reporting (MDR). UDI requirements. Labeling regulations. Design controls. Risk management (ISO 14971). Clinical evaluation requirements. Change control and post-market surveillance.

Skills & Abilities

Must possess excellent communication skills, and enjoy working with a diverse customer/employee base. Candidate should be proficient in the use of computer systems including MS Office and Outlook. Previous use of MRP/ERP systems and/or other databases and knowledge of manufacturing organization structure, policies, and procedures and a plus. Candidate must be able to deal with high intensity situations involving problems with multiple variables in a wide range of situations. Must be highly organized, a self-starter, able to prioritize and carry out multiple functions simultaneously.